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New words:
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Removed:
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Financial report summary
?Competition
Bristol-Myers Squibb • Astrazeneca • Rigel Pharmaceuticals • Cyclacel Pharmaceuticals • Jazz Pharmaceuticals • MEI Pharma • SELLAS Life Sciences • Syndax Pharmaceuticals • Kura Oncology • AbbvieRisks
- We have incurred significant net losses since inception, and we expect to incur significant losses over the next several years and may not be able to achieve or sustain revenues or profitability in the future.
- We have not generated any revenue from our product candidates and may never be profitable.
- We will need substantial additional funding. If we are unable to raise capital when needed, we would be compelled to delay, reduce or eliminate our product development programs or commercialization efforts.
- Our recently implemented corporate restructuring to optimize our resource allocation and contain costs may not have the benefits we expect.
- We have a limited operating history and face significant challenges and will incur substantial expenses as we build and maintain our capabilities.
- We may not realize any benefits of our asset acquisition from Gilead or any future acquisitions or strategic transactions.
- Our discovery and development activities are focused on novel cancer therapeutics for patients with genetically-defined cancers and it is difficult to predict the time and cost of product candidate development and the likelihood of obtaining regulatory approval.
- We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
- If we experience delays or difficulties in enrolling patients in our ongoing or planned clinical trials, regulatory approval could be delayed or we could fail to obtain regulatory approval.
- If adverse side effects or unexpected characteristics are identified during the development of our product candidates, we may need to abandon or limit the development of a product candidate.
- Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available, and are subject to audit and verification procedures that could result in material changes in the final data.
- We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- Our approach to the discovery and development of product candidates is unproven, and we may not be successful in our efforts to use and further develop our product engine to expand our pipeline of product candidates with commercial value.
- As a company, we have not completed any clinical trials to date.
- Because of the relatively small number of patients that are being or are planned to be dosed in our Phase 1/2 trial of KB-0742, the results of the clinical trial, if completed, may be less reliable than results achieved in larger clinical trials, which may hinder our efforts to further develop and obtain regulatory approval for this product candidate.
- If the market opportunities for our product candidates are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, it will adversely affect our revenue potential and ability to achieve profitability.
- Even if any of our product candidates are approved, they may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
- We currently have no marketing and sales organization and have no experience as a company in marketing products. If we are unable to establish and maintain marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, if approved, we may not be able to generate product revenue.
- Product liability lawsuits could cause us to incur substantial liabilities and could limit the commercialization of any product candidates that we develop.
- Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement policies, third-party reimbursement practices, or health care reform initiatives, which could harm our business.
- We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
- A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
- We may be unable to obtain U.S. or foreign regulatory approvals and, as a result, may be unable to commercialize our product candidates.
- We are currently conducting, and may in the future conduct clinical trials for our product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
- Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
- Even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions on marketing or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems.
- The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
- Disruptions at the FDA, the SEC or other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- We may face difficulties from changes to current regulations and future legislation.
- Our relationships with healthcare professionals, clinical investigators, CROs and third party payors in connection with our current and future business activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, and government price reporting, which could expose us to, among other things, criminal sanctions, administrative and civil penalties, contractual damages, exclusion from governmental healthcare programs, reputational harm, administrative burdens and diminished profits and future earnings.
- We are subject to stringent and changing U.S. and foreign laws, regulations, and rules, contractual obligations, policies, industry standards, and other obligations related to data privacy and information security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation (including class claims); fines and penalties; a disruption of our business operations; reputational hard; and other adverse business impacts.
- Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business.
- Our research and development activities could be affected or delayed as a result of possible restrictions on animal testing.
- We may be subject to U.S. and foreign anti-bribery and anti-corruption laws with respect to our operations, as well as U.S. and certain foreign export controls, trade sanctions, and import laws and regulations. Non-compliance with these laws can subject us to criminal or civil liability and harm our business.
- Our success depends in part on our ability to protect our intellectual property and our proprietary technologies.
- If we fail to comply with our obligations in the agreements under which we license or otherwise acquire intellectual property rights from our licensors and third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business or our business may otherwise be materially harmed.
- If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of the patent protection we have, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected.
- The patent protection and patent prosecution for some of our product candidates may be dependent on our licensors and third parties.
- Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
- Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.
- We may become involved in lawsuits or administrative disputes to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.
- Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
- Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
- We, or our licensors, may be subject to claims by third parties asserting that our, or our licensor’s, employees or consultants or we, or our licensors, have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
- Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
- If we or our licensors do not obtain patent term extension for our product candidates, our business may be materially harmed.
- We may not be able to protect our intellectual property rights throughout the world.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
- We rely on third parties, including independent clinical investigators, developers of companion diagnostics, and CROs, to conduct certain aspects of our preclinical studies and ongoing and planned clinical trials. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.
- If our collaboration with Genentech does not result in the successful discovery, development, and commercialization of product candidates or if it were to be terminated, our business could be adversely affected.
- We may form or seek collaborations or strategic alliances or enter into additional strategic arrangements in the future, which involve risks, and we may not realize the benefits of such collaborations, alliances or strategic arrangements.
- We will rely on third parties to manufacture our clinical product supplies, and we may rely on third parties to produce and process our product candidates, if approved.
- Manufacturing our product candidates is complex and we may encounter difficulties in production. If we encounter such difficulties, our ability to provide supply of our product candidates for preclinical studies and clinical trials or for commercial purposes could be delayed or stopped.
- If our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.
- Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees.
- In order to achieve our research, development and commercialization goals, we will need to grow the size of our organization and expand our capabilities, and we may experience difficulties in managing this growth.
- Our information technology systems, or those used by our third-party CROs or other contractors or consultants, may fail, be disrupted or suffer security breaches, which could result in a material disruption of our discovery and development programs or otherwise materially and adversely affect our business.
- If our information technology systems or data, or those of the third parties upon which we rely, are or were compromised, we could experience adverse impacts resulting from such compromise, including, but not limited to, regulatory investigations or actions, litigation, fines and penalties, interruptions to our operations such as our clinical trials, claims that we breached our data protection obligations, harm to our reputation, and a loss of future customers or sales and other adverse consequences.
- Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
- Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
- Provisions in our corporate charter documents and under Delaware law could make a merger, tender offer or proxy contest difficult, thereby depressing the trading price of our common stock.
- Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America will be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
- The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
- Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
- Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
- Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be the sole source of gain for our stockholders.
- We could be subject to securities class action litigation.
- If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about us, our business or our market, our stock price and/or trading volume could decline.
- An active trading market for our common stock may not be sustained.
- We incur substantial costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives and corporate governance practices.
- Unstable market, economic and geo-political conditions may have serious adverse consequences on our business, financial condition and stock price.
- Our business could be negatively impacted by environmental, social and corporate governance (ESG) matters or our reporting of such matters.
- We have recorded, and may be required to record in the future, significant charges if our long-lived assets become impaired.
Management Discussion
- Revenue was $6.3 million for the year ended December 31, 2023 and zero for the year ended December 31, 2022. The Collaboration and License Agreement with Genentech was entered into in January 2023. We recognize revenue from upfront payments over the term of our estimated period of performance under the agreement using a cost-based input method for the entire performance obligation.
- Research and development expenses were $86.4 million for the year ended December 31, 2023, compared to $93.7 million for the year ended December 31, 2022. The decrease of $7.3 million was primarily due to a decrease of $5.0 million in consulting and other outside research expenses primarily related to the discontinuation of our Phase 3 entospletinib trial in 2022, a decrease of $5.4 million in personnel costs primarily attributable to a $3.0 million decrease in stock-based compensation primarily due to a lower grant date fair value throughout 2023 and a decrease of $2.4 million in personnel costs primarily due to attrition in the research and development organization. These decreases were partially offset by a $3.1 million increase in facilities, depreciation and other expenses, primarily consisting of a $1.9 million non-cash impairment charge related to lease assets and leasehold improvements. Please refer to Item 8 Financial Statements and Supplementary Data, Note 8 “Commitment and Contingencies - Impairment of Operating Lease Right-of-Use Asset and Other Long-Lived Assets” for further details.
- General and administrative expenses were $41.7 million for the year ended December 31, 2023 compared to $43.4 million for the year ended December 31, 2022. The decrease of $1.7 million was primarily due to a $3.2 million decrease in stock-based compensation which is comprised of the impact of a lower grant date fair value throughout 2023 in addition to a $1.0 million reversal of expense in connection with equity award forfeitures upon the departure of our Chief Financial Officer in September 2023, and a decrease of $2.3 million in professional fees primarily attributable to insurance and other professional services. These decreases were partially offset by an increase of $2.6 million in personnel expenses primarily driven by an increase of $2.2 million in salary and wages due to the increased headcount in the first ten months of 2023 before the reduction in force occurred in November 2023, and an increase of $1.1 million in facilities, depreciation and other expenses driven by a non-cash impairment charge of $1.1 million. Please refer to Item 8 Financial Statements and Supplementary Data, Note 8 “Commitment and Contingencies -Impairment of Operating Lease Right-of-Use Asset and Other Long-Lived Assets” for further details.